Apparatus and method used with guidance system for feeding and suctioning

ABSTRACT

In one example embodiment, the tube assembly is configured to be used in conjunction with a tube assembly guidance system. The tube assembly includes a first connector, a feeding tube connected to the first connector, a second connector connected to the feeding tube, and a suctioning tube connected to the second connector. The suctioning tube is configured to receive the feeding tube. The feeding tube is configured to allow enteral feeding while the suctioning tube is configured to allow suctioning or decompression of a patient&#39;s stomach.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of, and claims the benefitof and priority to, U.S. patent application Ser. No. 13/606,977, filedon Sep. 7, 2012, which is a non-provisional of U.S. Provisional PatentApplication Ser. No. 61/532,187, filed on Sep. 8, 2011, the entirecontent of each of which is hereby incorporated by reference herein.

BACKGROUND

Physicians and other health care providers frequently use catheters totreat patients. Catheters include a tube which is inserted into thehuman body. Certain catheters are inserted into through the patient'snose or mouth for treating the gastrointestinal tract. These catheters,sometimes referred to as enteral catheters, typically include feedingtubes. The feeding tube lies in the stomach or intestines, and a feedingbag delivers liquid nutrient, liquid medicine or a combination of thetwo to the patient. When a feeding tube is inserted though a patientsnare, and it is determined that a patient cannot be fed into thestomach, a second tube is typically inserted through the patient's othernare.

When using catheters, it is important to place the end of the catheterat the proper location within the human body. Erroneous placement of thecatheter tip may injure or harm the patient. For example, if the healthcare provider erroneously places an enteral catheter into the patient'slungs, liquid may be introduced into the lungs with harmful results. Ifthe health care provider erroneously places a catheter into the wrongcavity of the cardiovascular system, the patient may experienceinfection or a harmful blockage.

In some cases, health care providers use X-ray machines to gatherinformation about the location of the catheters within the body. Thereare several of disadvantages with using X-ray machines. For example,X-rays from these machines are a known carcinogen, if received insufficient doses. Also, X-ray machines are relatively large and heavy,consume a relatively large amount of energy and may expose the patientto a relatively high degree of radiation. Also, these machines aretypically not readily accessible for use because, due to their size,they are usually installed in a special X-ray room. This room can berelatively far away from the patient's room. Therefore, health careproviders can find it inconvenient to use these machines for theircatheter procedures. Furthermore, it can be inconvenient to transportthese machines to a patient's home for home care catheter procedures.

Accordingly, there is a need to overcome each of these disadvantages.

SUMMARY

In one example embodiment, the tube assembly is configured to allow: (a)enteral feeding; and (b) gastric suctioning or decompression. In oneexample embodiment, the tube assembly is configured to be used inconjunction with a tube assembly guidance system. In one exampleembodiment, the tube assembly includes a first connector and a feedingtube having: (a) a first end connected to the first connector; and (b) asecond end configured to allow enteral feeding. In example embodiment,the tube assembly includes a second connector connected to the feedingtube. In one example embodiment, the tube assembly includes a suctioningtube configured to receive the feeding tube. In one example embodiment,the suctioning tube has: (a) a third end connected to the secondconnector; and (b) a portion configured to be placed through a patient'snare. In one example embodiment, the portion includes a fourth endconfigured to allow suctioning or decompression of the patient'sstomach.

In one example embodiment, the tube assembly includes a magnetic fieldgenerator.

In one example embodiment, the second end and the fourth end areconfigured to be simultaneously advanced into the patient's stomach.

In one example embodiment, after the second end and the fourth end areplaced into the patient's stomach: (a) feeding can be achieved using thefeeding tube; and (b) suctioning can be achieved using the tube.

In one example embodiment, the second connector is releaseably connectedto the feeding tube such that, after the second end the fourth end areplaced into the patient's stomach, the second end is configured to beadvanced from the patient's stomach into a small bowel of the patientwhile the fourth end remains in the patient's stomach.

In one example embodiment, the tube assembly includes a sleeveconfigured to secure the third end to the second connector.

In one example embodiment, the tube assembly includes a plug configuredto stabilize a position of the feeding tube relative to the suctioningtube.

In one example embodiment, the first connector includes a first y-portconnector, and the second connector includes a second y-port connector.

In one example embodiment, a method of tracking a first end of a feedingtube and a second end of a suctioning tube which in configured toreceive the feeding tube includes: (a) causing a processor to executeinstructions to operate with a display device to display a referenceimage; (b) causing the processor to execute the instructions to, using amagnetic field generator, operate with the display device to display afirst position of the first end and the second end; and (c) thereafter,causing the processor to execute the instructions to operate with thedisplay device to display a second position of the first end, the secondposition being different from the first position based on the first endbeing advanced into a lower intestine of the patient, the second endremaining at the first position.

The tube assembly disclosed herein thus is used with only one nare ofthe patient and is for both feeding and suctioning. If gastric feedingis not tolerated by the patient's stomach, the feeding tube can beadvanced into the small bowel of the patient with the aid of a tubeassembly guidance system, thereby eliminating the need to transport thepatient to a Radiology Unit or Gastroenterology Unit. Advancing thefeeding tube and suctioning tube at the bedside reduces therapydowntime, x-ray exposure and costly procedures practiced in Radiology orGastroenterology.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a top or plan view of one example embodiment of the catheterunit and the display device, illustrating an enteral applicationinvolving a portion of the tubing assembly inserted into a human bodyand indication of catheter information on the display device.

FIG. 2 is schematic block diagram of one example embodiment of theelectronic configuration of the catheter position guidance system,illustrating the processor, memory device, signal generator, inputdevices and output devices.

FIG. 3 is a perspective view of one example embodiment of the catheterunit, illustrating the tubing assembly and the signal generator beingreceived by and housed in the tubing assembly.

FIG. 4 is a perspective view of one example embodiment of the tubingassembly, illustrating the suctioning tube receiving the feeding tube.

FIG. 5 is a perspective view of one example embodiment of the catheterunit showing, illustrating the tubing assembly and the signal generatingassembly.

FIGS. 6A, 6B and 6C are top or plan views of one example embodiment ofcertain portions of the tube assembly, illustrating an end of thefeeding tube being advanced to the patient's small bowel after the endof the feeding tube and the end of the suctioning tube have been placedin the patient's stomach.

DETAILED DESCRIPTION

FIGS. 1 and 2 depict a catheter position guidance system not unlike thatdescribed in U.S. Pat. No. 7,976,518. That patent is hereby incorporatedinto this specification by reference. Where a definition or use of aterm in U.S. Pat. No. 7,976,518 is inconsistent or contrary to thedefinition of that term provided herein, the definition of that termprovided herein applies and the definition of that term in the referencedoes not apply.

This invention also relates to a method of catheter location in a humanbody not unlike that described in U.S. Patent Publication No.2010/0097373. That patent publication is hereby incorporated into thisspecification by reference. Where a definition or use of a term in U.S.Patent Publication No. 2010/0097373 is inconsistent or contrary to thedefinition of that term provided herein, the definition of that termprovided herein applies and the definition of that term in the referencedoes not apply.

Referring now to the drawings, in one example illustrated in FIGS. 1 and2, the catheter position guidance system or catheter guidance system 2includes: (a) an apparatus 10 having a housing 18 which supports acontroller or processor 20 and a display device 22; (b) a non-invasivemovable receiver-transmitter or transceiver 32 electronically coupled tothe processor 20 by a wire, cable, signal data connection or signalcarrier 62; and (c) an invasive catheter unit 12 in communication withthe transceiver 32 and operatively coupled to the apparatus 10 by awire, cable, chord or electrical extension 34, which, in turn, isoperatively coupled to the processor 20. It should be appreciated thatthe transceiver 32 can include a device which has a separate signalreceiver and signal transmitter. The transceiver 32 can also include asingle device which functions so as to receive and transmit signals.

As best illustrated in FIG. 2, the system, in one example embodiment,includes: (a) a plurality of input devices 17 for providing inputsignals to the system 2 such as one or more control buttons 29, a touchscreen 31 and the transceiver 32; (b) a signal generating assembly 16which produces or generates electronic signals that are received by thetransceiver 32; (c) a memory device 21 including machine readableinstructions and one or more computer programs (which, for example, mayinclude a plurality of algorithms 23) which are used by the processor 20to process the signal data produced by the signal generating assembly 16and transmitted by the transceiver 32; and (d) a plurality of outputdevices 19 such as the display device 22 and the printer 28 whichindicate the catheter information to the health care provider. Thedisplay device 22 may be any suitable display mechanism including, butnot limited to, a liquid crystal display (LCD), light-emitting diode(LED) display, cathode-ray tube display (CRT) or plasma screen.

Health care providers can use the system 2 in a variety of catheterapplications. In one example illustrated in FIG. 1, the system 2 is usedin an enteral application. Here, a portion 70 of the catheter unit 12 isplaced through the patient's nose 72. The distal end or tip 60 of thecatheter unit 12 is positioned in the lower intestine, morespecifically, in the patient's jejunum 77. Here, the end of thesuctioning tube 51 remains positioned in the patient's stomach 74. Thehealth care provider places the transceiver 32 over the chest area 76 ofa body 78. The display device 22 and the printer 28 indicate informationrelated to the location of the portion 70 of the catheter unit 12 withinthe body 78, as well as information related to the shape of the pathwaytaken by the catheter unit 12. It should be appreciated that the system2 need not indicate the exact location or path of the catheter unit 12to provide assistance to the health care provider.

Referring to FIGS. 3 to 5, in one example embodiment, the catheter unit12 includes a tubing assembly 14 which receives and houses the signalgenerating assembly 16.

In one example embodiment, the tubing assembly 14 includes: (a) a tubeor an electrical tubular insulator 40; (b) a first connector such as amulti-port connector or y-port connector 44 attachable to the tubularinsulator 40; (c) a second tube such as a catheter or a feeding tube 50,connected to the y-port connector 44; (d) a second connector such asecond multi-port connector or second y-port connector 45, connected tothe feeding tube 50; a third tube such a second catheter or a suctioningtube 51; and (e) a feeding tube end, bolus or tip 60 attached to thedistal end of the feeding tube 50.

In one example embodiment, the multi-port or y-port connector 44includes: (a) a liquid delivery branch, medicine delivery branch ormedicine branch 142 for distributing drugs, medicine or other medicinalliquids to the patient; (b) a nutrient delivery branch or feeding branch144 sized to receive the insert 124 of the tubular insulator 40; (c) acatheter or feeding tube connection branch 146 attached to the feedingtube 50; (d) a flexible or movable arm 148; and (e) a flexible ormoveable arm 150. In an alternative embodiment, y-port connector 44includes additional branches for administering various nutrients ormedicines to the body 78. In another alternative embodiment, the y-portconnector 44 includes only a feeding branch 144 and a connection branch146. The arm 148 has a stopper 152, and the arm 150 has a stopper 154.The stoppers 152 and 154 are sized to prevent fluid from passing throughthe branches 142 and 144 after such branches 142 and 144 are pluggedwith stoppers 152 and 154, respectively. In addition, the arm 150includes a fastener which secures a tube-size adapter to the arm 150.The tube-size adapter enables fluid delivery tubes (not shown) havingvarious diameters to connect to the feeding branch 144 of the y-portconnector 44.

In one example embodiment, the feeding tube 50 includes: (a) a proximalend attached to the catheter connection branch 146 of the y-portconnector 44; (b) a distal end; and (c) an external surface. Theproximal end is insertable into the feeding tube connection branch 146of the y-port connector 44 so as to bring the feeding tube 50 into fluidcommunication with the y-port connector 44. In one embodiment, theexternal surface has a plurality of volumetric, measurement or unitmarkings uniformly spaced along the body of the feeding tube. Thesemarkings assist the user in measuring the flow or distribution of liquidto or from the patient. In an alternative embodiment, markings functionas placement markers which assist the user in assessing the depth thatthe feeding catheter is placed within the human body.

In one example embodiment, the end member, bolus or tip 60 is attachedto the distal end of the feeding tube 50. The tip 60 includes a bodyhaving a collar and an end member. The body defines a passage and anopening. The opening is positioned between the collar and the endmember. A portion of the end member can have a rounded shape. The shapeof the passage and opening of the tip 60 is configured to facilitate theflow of fluid from the feeding tube 50 into the patient's body whiledecreasing the likelihood that the opening will become clogged.

In one example embodiment, the second multi-port or y-port connector 45includes: (a) a suctioning branch 143 which can be used for suctioningto check gastric residuals; (b) a suctioning branch 145 sized to receivethe feeding tube 50; (c) a second catheter or suctioning tube connectionbranch 147 attached to the suctioning tube 51; (d) a flexible or movablearm 149; and (e) a flexible or moveable arm 151. The arm 149 has astopper 153, and the arm 151 has a stopper 155. The stoppers 153 and 155are sized to prevent air and/or fluid from passing through the branches145 and 147 after such branches 145 and 147 are plugged with stoppers153 and 155, respectively.

In one example embodiment, the tubing assembly includes a plug which isconfigured to be inserted into the second nutrient delivery branch 145.In this example embodiment the plug is configured to stabilize aposition of the feeding tube relative to second multi-port connector andthus also the suctioning tube.

In one example embodiment, the suctioning tube 51 includes: (a) aproximal end attached to the suctioning tube connection branch 147 ofthe y-port connector 45; (b) a distal end; and (c) an external surface.The proximal end is insertable into the catheter connection branch 147of the y-port connector 45 so as to bring the suctioning tube 51 intofluid communication with the y-port connector 45. In one embodiment, theexternal surface has a plurality of volumetric, measurement or unitmarkings uniformly spaced along the body of the suctioning tube. In oneexample embodiment, markings function as placement markers which assistthe user in assessing the depth that the suctioning tube is placedwithin the human body.

In one example embodiment, the tubing assembly includes a sleeve 157which is configured to help secure the suctioning tube 51 to the secondconnector 45.

The tubular connector 40, y-port connector 44, y-port connector 45,feeding tube 50 and suctioning tube 51 can be made from any suitablepolymer or plastic material including, but not limited to, polyamide,polyethylene, polypropylene, polyurethane, silicone andpolyacrylonitrile.

In one example embodiment, the invasive signal generating assembly 16includes a magnetic energy generator or magnetic field generator 58operatively coupled to the distal end of a wire assembly 38. The tubularinsulator 40 described above covers a portion of the wire assembly 38.

In operation, when the apparatus 10 sends electrical current to coils ofthe magnetic field generator 58, and the coils transmit a signal orelectromagnetic field capable of being detected by the non-invasivetransceiver 32. The transceiver 32 detects the electromagnetic field orsignal generated by the magnetic field generator 58 inside the humanbody. The processor 20 causes the display device 22 and the printer 28to produce graphics which assist the health care provider in thecatheter placement procedure.

In one example embodiment, the method of tracking the placement of thegenerator 58 includes first step of determining the length of thefeeding tube 50 and the suctioning tube 51. Next, prior to placing thesuctioning tube 51 into the human body for suctioning and the feedingtube 50 into the human body for enteral feeding, the user or assemblerplaces the magnetic field generator 58 at a desired location within thefeeding tube 50.

Once the position of the generator 58 has been properly set, the healthcare provider places the transceiver 32 on the patient's chest andinserts the suctioning tube 51 and the feeding tube 50 into thepatient's stomach through a patient's nare. While doing so, the displaydevice 22 displays graphics 37 that help the user in guiding the end ofthe suctioning tube 51 and the end of the feeding tube 50 to a desiredlocation within the human body. Once the end of the suctioning tube 51and the end of the feeding tube 50 are placed in the desired location,the user can remove the signal generating assembly 16 while the positionof the suctioning tube 51 and the feeding tube 50 is maintained as shownin FIG. 6A. The user then attaches medicine and nutritional deliverytubes to the y-port connector 44 for introducing fluids into the bodyfor medical treatment.

Thereafter, if it is determined that the stomach cannot handle feeding,the signal generating assembly is reinserted into the feeding tube 50,and the end of the feeding tube 50 is advanced into the small bowel ofthe patient as shown in FIGS. 6B and 6C. While doing so, the displaydevice 22 displays graphics 37 that help the user in guiding the end ofthe feeding tube 50 to a desired location within the human body. Oncethe end of the feeding tube 50 is placed in the desired location, theuser removes the signal generating assembly 16 while the position of thesuctioning tube 51 and the feeding tube 50 is maintained. The user canthen reattach the medicine and nutritional delivery tubes to the y-portconnector 44 for introducing fluids into the body for medical treatment.In this example embodiment, as the end of the feeding tube is advancedto the patient's small bowel, the end of the suctioning tube 51 remainsin the patient's stomach to allow suctioning and decompression as shownin FIGS. 6B and 6C.

It should also be appreciated that these procedures may involvetreatment of humans by physicians, physician assistants, nurses or otherhealth care providers. In addition, these procedures may involvetreatment of other mammals and animals by veterinarians, researchers andothers.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A tube assembly for: (a) enteralfeeding; and (b) gastric suctioning or decompression, the tube assemblyconfigured to be used in conjunction with a tube assembly guidancesystem, the tube assembly comprising: a first connector; a feeding tubehaving: (a) a first end connected to the first connector; and (b) asecond end configured to allow enteral feeding; a second connectorconnected to the feeding tube; a suctioning tube configured to receivethe feeding tube, the suctioning tube having: (a) a third end connectedto the second connector; and (b) a portion configured to be placedthrough a patient's nare, the portion including a fourth end configuredto allow suctioning or decompression of the patient's stomach.
 2. Thetube assembly of claim 1, which includes a magnetic field generator. 3.The tube assembly of claim 1, wherein the second end and the fourth endare configured to be simultaneously advanced into the patient's stomach.4. The tube assembly of claim 1, wherein after the second end and thefourth end are placed into the patient's stomach: (a) feeding can beachieved using the feeding tube; and (b) suctioning can be achievedusing the tube.
 5. The tube assembly of claim 1, wherein the secondconnector is releaseably connected to the feeding tube such that, afterthe second end the fourth end are placed into the patient's stomach, thesecond end is configured to be advanced from the patient's stomach intoa small bowel of the patient while the fourth end remains in thepatient's stomach.
 6. The tube assembly of claim 1, which includes asleeve configured to secure the third end to the second connector. 7.The tube assembly of claim 1, which includes a plug configured tostabilize a position of the feeding tube relative to the suctioningtube.
 8. The tube assembly of claim 1, wherein: (a) the first connectorincludes a first y-port connector; and (b) the second connector includesa second y-port connector.
 9. A method of tracking a first end of afeeding tube and a second end of a suctioning tube which in configuredto receive the feeding tube, the method comprising: (a) causing aprocessor to execute instructions to operate with a display device todisplay a reference image; (b) causing the processor to execute theinstructions to, using a magnetic field generator, operate with thedisplay device to display a first position of the first end and thesecond end; and (c) thereafter, causing the processor to execute theinstructions to operate with the display device to display a secondposition of the first end, the second position being different from thefirst position based on the first end being advanced into a lowerintestine of the patient, the second end remaining at the firstposition.